Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90623419 | 9062341 | 9 | F | 20150410 | 20160712 | 20130213 | 20160718 | EXP | US-GLAXOSMITHKLINE-A1007359A | GLAXOSMITHKLINE | 79.18 | YR | F | Y | 0.00000 | 20160718 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90623419 | 9062341 | 1 | PS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | CONTINUOUS37 NG/KG/MIN CONTINOUSLYCONCENTRATION: 60,000 NG/MLVIAL STRENGTH 1.5 MG | U | N145 | 20444 | 36 | DF | POWDER FOR INFUSION | |||||
| 90623419 | 9062341 | 2 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | N145 | 20444 | POWDER FOR INFUSION | ||||||||
| 90623419 | 9062341 | 3 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | R529 | 20444 | POWDER FOR INFUSION | ||||||||
| 90623419 | 9062341 | 4 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | U052 | 20444 | POWDER FOR INFUSION | ||||||||
| 90623419 | 9062341 | 5 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | UNK | U | 20444 | POWDER FOR INFUSION | |||||||||
| 90623419 | 9062341 | 6 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Unknown | 38 UNK, CO | U | V785 | 20444 | 38 | DF | POWDER FOR INFUSION | |||||
| 90623419 | 9062341 | 7 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | 38 NG/KG/MIN (CONCENTRATION 45,000, PUMP RATE 64 ML/DAY, VIAL STRENGTH 1.5 MG/ML), CO | U | Z111 | 20444 | POWDER FOR INFUSION | ||||||||
| 90623419 | 9062341 | 8 | SS | FLOLAN | EPOPROSTENOL SODIUM | 1 | Intravenous (not otherwise specified) | 38 NG/KG/MIN CONTINUOUS | U | Z606 | 20444 | 38 | DF | POWDER FOR INFUSION | |||||
| 90623419 | 9062341 | 9 | C | REVATIO | SILDENAFIL CITRATE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 90623419 | 9062341 | 1 | Pulmonary arterial hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 90623419 | 9062341 | HO |
| 90623419 | 9062341 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 90623419 | 9062341 | Atrial fibrillation | |
| 90623419 | 9062341 | Cardiac failure | |
| 90623419 | 9062341 | Cystitis | |
| 90623419 | 9062341 | Diarrhoea | |
| 90623419 | 9062341 | Drug dose omission | |
| 90623419 | 9062341 | Hospitalisation | |
| 90623419 | 9062341 | Nausea | |
| 90623419 | 9062341 | Neoplasm | |
| 90623419 | 9062341 | Pallor | |
| 90623419 | 9062341 | Peripheral swelling | |
| 90623419 | 9062341 | Pneumonia | |
| 90623419 | 9062341 | Upper respiratory tract infection |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 90623419 | 9062341 | 1 | 20060202 | 0 | ||
| 90623419 | 9062341 | 2 | 20060203 | 0 | ||
| 90623419 | 9062341 | 3 | 20060203 | 0 | ||
| 90623419 | 9062341 | 4 | 20060203 | 0 | ||
| 90623419 | 9062341 | 6 | 20060202 | 0 | ||
| 90623419 | 9062341 | 8 | 20060202 | 0 |